Early and Long-Term Responses to Anti-Vascular Endothelial Growth Factor Therapy in Diabetic Macular Edema: Analysis of Protocol I Data.

Abstract

PURPOSE:

To determine whether early visual acuity response to ranibizumab in diabetic macular edema is associated with long-term outcome.

DESIGN:

Post hoc analysis of randomized controlled trial data.

METHODS:

Pooled data from the ranibizumab plus prompt and deferred laser treatment arms of the Diabetic Retinopathy Clinical Research Network's Protocol I study were used to explore the relationship between early (week 12) and late (weeks 52-156) visual acuity response (mean change from baseline in best-corrected visual acuity [CFB BCVA]; categorized improvement [<5, 5-9, or ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] in BCVA).

RESULTS:

In the analysis population (340 eyes), <5-, 5- to 9-, and ≥10-letter BCVA improvements occurred in 39.7%, 23.2%, and 37.1% of eyes, respectively, at 12 weeks, and 34.2%, 16.5%, and 49.3% of eyes at 156 weeks. Within each early BCVA response category (<5, 5-9, and ≥10 letters of improvement at 12 weeks), mean CFB BCVA at 52-156 weeks varied by <5 letters from that at 12 weeks. CFB BCVA and <5-letter improvement at 12 weeks showed significant positive and negative association, respectively, with CFB BCVA and ≥10-letter improvement at 52 and 156 weeks. Similar relationships were demonstrated in eyes with baseline BCVA <69 letters, and associations remained significant after multivariate adjustment for potential confounders.

CONCLUSIONS:

Ranibizumab ± laser therapy resulted in similar rates (∼40%) of suboptimal (<5-letter) and pronounced (≥10-letter) BCVA improvement at 12 weeks. Eyes with suboptimal early BCVA response showed poorer long-term visual outcomes than eyes with pronounced early response (mean improvement 3.0 vs 13.8 letters at 156 weeks).

• Authors: Victor H Gonzalez, Joanna Campbell, Nancy M Holekamp, Szilárd Kiss, Anat Loewenstein, Albert J Augustin, Julia Ma, Allen C Ho, Vaishali Patel, Scott M Whitcup, Pravin U Dugel
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 172 Pg. 72-79 (Dec 2016) ISSN: 1879-1891 [Electronic] United States
• PMID: 27644589 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Vascular Endothelial Growth Factor A
• Ranibizumab

Topics

• Angiogenesis Inhibitors (administration & dosage)
• Diabetic Retinopathy (complications, diagnosis, drug therapy)
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Intravitreal Injections
• Macular Edema (diagnosis, drug therapy, etiology)
• Male
• Middle Aged
• Ranibizumab (administration & dosage)
• Time Factors
• Tomography, Optical Coherence
• Treatment Outcome
• Vascular Endothelial Growth Factor A (antagonists & inhibitors)
• Visual Acuity